COMPARISON OF EFFICIENCY OF TAMSULOSIN VS SILODOSIN IN THE TREATMENT OF LOWER URETERIC CALCULUS-RANDOMISED CONTROLLED STUDY
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- STONE CLEARENCE RATE (%)
研究概览
简要总结
70% ureteric calculus are situated in lower 1/3rd of ureter, referred as Distal Ureteric Stones (DUS). Medical Expulsion Therapy(MET) has replaced minimally invasive procedures due to incidence of major complications including ureteric avulsions, perforation & strictures in the latter.
Uroselective Alfa adrenergic blockers as MET has been accepted as first line management of small lower ureteric calculus as various meta analysis shows stone passage of 44% - 52%. However MET has been associated with side effects including retrograde ejaculation.
Identification of α1A adrenoreceptor blocker capable of lesser side effects has been proposed as an alternative to α1 adreno receptor blocker.
The objective of study is to compare efficiecy of Tamsulosin vs Silodosin as MET of DUS in terms of stone clearence rate and stone expulsion time.
Randomisation will be achived by Block Randomisation and results are to be compared with appropriate statistical software.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •a) Unilateral distal ureteric calculus b) Size < 10 mm c) Normal renal parameters (Serum Urea & Serum Creatinine) d) Age 18-60 yrs.
排除标准
- •a) Single kidney b) Bilateral ureteric stone c) Mid/upper ureteric calculus d) Renal impairment e) High grade hydroureteronephrosis (Grade III & IV as per Society of Fetal Ultrasound, SFU) f) Any h/o previous endoscopic/ surgical/ ESWL interventions g) Intolerable side-effects (Hypotension) to either tamsulosin/ silodosin h) Evidence of UTI j) Concomitant kidney/bladder stones k) Patients already on any alpha blocker for BPH.
结局指标
主要结局
STONE CLEARENCE RATE (%)
时间窗: 1.Passing of stone | 2.04 weeks elapsed and surgical intervention planned | 3.Symptoms of patient demanding interventional procedures
次要结局
- STONE EXPULSION TIME (DAYS)(1.Passing of stone)